Class 2 Medicines Recall: Synalar GEL 30g, Synalar GEL 60g,(fluocinolone acetonide 0.025%) Reig Jofre UK,EL(25)A/16
It has been identified that the batches of Synalar Gel 30g and 60g listed in this notification contain a residual solvent (benzene) at a level exceeding the ICH limit of 2ppm. Reig Jofre UK are recalling the batches as a precautionary measure. This recall is at the pharmacy and wholesaler level.
DMRC reference number
DMRC-35165402
Marketing Authorisation Holder
Reig Jofre UK
Medicine Details
Synalar GEL 30g
PL: 44095/0004
Active ingredient: Fluocinolone Acetonide 0.025%
SNOMED code: 2156911000001100
GTIN: 8435373700332
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| L303A | 31/03/2026 | 1 | 19/05/2023 |
| L304A | 30/04/2026 | 1 | 21/08/2023 |
| L401A | 31/03/2027 | 1 | 10/06/2024 |
| L403A | 31/05/2027 | 1 | 17/10/2024 |
| L404A | 31/05/2027 | 1 | 17/10/2024 |
Medicine Details
Synalar GEL 60g
PL: 44095/0004
Active ingredient: Fluocinolone Acetonide 0.025%
SNOMED code: 11507311000001100
GTIN: 8435373700349
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| L301A | 28/02/2026 | 1 | 11/07/2023 |
| L402A | 31/03/2027 | 1 | 17/10/2024 |
Background
It has been identified that the batches listed in this notification of Synalar Gel 30g and 60g contain a residual solvent (benzene) at a level exceeding the ICH limit of 2ppm. This solvent has been identified from one of the excipients in the product, carbomer 940, and the theoretical results from the initial investigation prompted the testing of the retention samples. These results have shown some batches are within the limit, whilst some are over the 2ppm limit.
Reig Jofre UK are recalling all these affected batches as a precautionary measure. This recall is at pharmacy and wholesaler level. It is only the specific Synalar Gel batches listed in this notification that are affected. All other presentations of Synalar (Ointment and Cream) are not affected. Due to this recall, there will be a temporary shortage of Synalar Gel and Reig Jofre UK are unable to provide a specific date for when new stock will be available.
Advice for Healthcare Professionals:
Stop supplying the affected batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice for Patients:
No further action is required by patients as this is a pharmacy and wholesaler level recall.
Reig Jofre UK have confirmed that the patient risk due to this out of specification result is low based on the initial investigation and assessment, however the recall is a precautionary measure to mitigate any additional dispensing of the product batches.
Patients are advised not to stop any treatments without consulting your relevant healthcare professional. If you have any concerns in relation to the product or any side effects, please contact your pharmacist or GP for more information and assistance.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional information:
For medical information enquiries please contact Reig Jofre UK Medical Information on 0330 1359 434 or by email MedInfoUK@reigjofre.com.
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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